Esophageal Cancer Clinical Trial

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

Summary

This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
ECOG PS ≤ 1 within 7 days prior to randomization
Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization

Key Exclusion Criteria:

Has squamous cell or undifferentiated or other histological type GC
Active leptomeningeal disease or uncontrolled brain metastasis
Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
Prior therapy with an anti-PD-1, anti-immunotherapy-drugs-are-boosting-survival/" >PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

997

Study ID:

NCT03777657

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 128 Locations for this study

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University of California Davis Health System
Sacramento California, 95817, United States
Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
Ohio State University Hospital
Columbus Ohio, 43210, United States
Thomas Jefferson University Hospital - Central
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Reading Hospital
West Reading Pennsylvania, 19611, United States
Tennessee Oncology, PLLC - Nashville
Nashville Tennessee, 37203, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu Anhui, 23300, China
Anhui Provincial Cancer Hospital
Hefei Anhui, 23008, China
The Second Hospital of Anhui Medical University
Hefei Anhui, 23120, China
Beijing Chao Yang Hospital
Beijing Beijing, 10002, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing Beijing, 10002, China
Peking Union Medical College Hospital
Beijing Beijing, 10003, China
Beijing Friendship Hospital, Capital Medical University
Beijing Beijing, 10005, China
No. 3 Hospital, Beijing University
Beijing Beijing, 10008, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Chinese PLA General Hospital Medical School of Chinese PLA
Beijing Beijing, 10085, China
Beijing Luhe Hospital
Beijing Beijing, 10110, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou Fujian, 35000, China
Fujian Cancer Hospital
Fuzhou Fujian, 35001, China
The First Hospital of Lanzhou University
Lanzhou Gansu, 73000, China
The First People's Hospital of Foshan
Foshan Guangdong, 52800, China
Sun Yat-sen University, Cancer Center
Guangzhou Guangdong, 51006, China
Guangdong General Hospital
Guangzhou Guangdong, 51008, China
Shenzhen People's Hospital
Shenzhen Guangdong, 51802, China
The First Affiliated Hospital of Guilin Medical University
Guilin Guangxi, 41000, China
Hainan General Hospital
Haikou Hainan, 57031, China
Fourth Hospital of Hebei Medical University
Shijiazhuang Hebei, 50051, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15008, China
Henan Provincial People's Hospital
Zhengzhou Henan, 45000, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou Henan, 45005, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Hunan Cancer Hospital
Changsha Hunan, 41000, China
Xiangya Hospital Central South University
Changsha Hunan, 41000, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing Jiangsu, 21000, China
Jiangsu Cancer Hospital
Nanjing Jiangsu, 21000, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21002, China
Nantong Tumor Hospital
Nantong Jiangsu, 22636, China
The Second Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
The First Hospital of Jilin University
Changchun Jilin, 13000, China
The First Hospital of China Medical University
Shenyang Liaoning, 11000, China
General Hospital of Shenyang Military Region
Shenyang Liaoning, 11001, China
Liaoning Cancer Hospital & Institute
Shenyang Liaoning, 11004, China
Shandong Cancer Hospital
Jinan Shandong, 25011, China
Linyi Cancer Hospital
Linyi Shandong, 27600, China
The Affiliated Hospital of Qingdao University
Qingdao Shandong, 26607, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Shanghai Shanghai, 20002, China
Zhongshan Hospital Fudan University
Shanghai Shanghai, 20003, China
Shanghai General Hospital
Shanghai Shanghai, 20008, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai Shanghai, 20009, China
Daping Hospital of The 3rd Military University
Chongqing Sichuan, 40004, China
Tianjin Medical University General Hospital
Tianjin Tianjin, 30005, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, 30006, China
Yunnan Cancer Hospital
Kunming Yunnan, 65011, China
The First Affiliated Hospital, Zhejiang University
Hangzhou Zhejiang, 31000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou Zhejiang, 31001, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Centre Antoine Lacassagne
Nice cedex 02 Alpes Maritimes, 06189, France
Centre Georges François Leclerc
Dijon cedex Côte-d'Or, 21079, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac Gironde, 33604, France
CHU Besançon - Hôpital Jean Minjoz
Besançon , , France
Hôpital de la Timone
Marseille , , France
Hôpital Nord Franche Comté
Montbéliard , , France
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Torrette Ancona, 60020, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo Foggia, 71013, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli , 80131, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padova , 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa , 56126, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma , 133, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Chiba Cancer Center
Chiba-shi Chiba-Ken, 260-8, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi Chiba-ken, 296-8, Japan
Fukui Prefectural Hospital
Fukui-shi Fukui-ken, 910-8, Japan
NHO Kyushu Cancer Center
Fukuoka-shi Fukuoka-Ken, 811-1, Japan
Gunma Prefectural Cancer Center
Ota-shi Gunma -ken, 373-8, Japan
NHO Takasaki General Medical Center
Takasaki-shi Gunma-ken, 370-0, Japan
Hiroshima City Hiroshima Citizens Hospita
Hiroshima-shi Hiroshima-ken,, 730-8, Japan
Hokkaido University Hospital
Sapporo-shi Hokkaido, 060-8, Japan
JOHAS Kansai Rosai Hospital
Amagasaki-shi Hyogo-ken, 660-8, Japan
Ishikawa Prefectural Central Hospital
Kanazawa-shi Ishikawa-ken, 920-8, Japan
Kagawa University Hospital
Kita-gun Kagawa-Ken, 761-0, Japan
Kanagawa Cancer Center
Yokohama Kanagawa, 241-8, Japan
Oita University Hospital
Yufu-shi Oita-Ken, 879-5, Japan
Kurashiki Central Hospital
Kurashiki-shi Okayama-ken, 710-8, Japan
Okayama University Hospital
Okayama-shi Okayama-ken, 700-8, Japan
Izumi City General Hospital
Izumi-shi Osaka-Fu, 594-0, Japan
NHO Osaka National Hospital
Osaka-shi Osaka-fu, 540-0, Japan
Osaka International Cancer Institute - Clinical Oncology
Suita Osaka, 537-8, Japan
Osaka University Hospital
Suita Osaka, 565-0, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama-ken, 350-1, Japan
Saitama Cancer Center
Ina Saitama, , Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu-shi Shizuoka-Ken, 431-3, Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka-fu Takatsuki-shi, 569-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo-To, 104-0, Japan
Tokyo Metropolitan Tama Medical Center
Fuchu-shi Tokyo-to, 183-8, Japan
Cancer Institute Hospital of JFCR
Koto-ku Tokyo-To, 135-8, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku Tokyo-To, 162-8, Japan
Kurashiki Central Hospital
Kurashiki , 710-8, Japan
Osaki Citizen Hospital
Osaka , 989-6, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Severance Hospital, Yonsei University
Seoul Gyeonggi-do, 03722, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si Gyeonggi-do, 16247, Korea, Republic of
Ajou University Hospital
Suwon Gyeonggi-do, 16499, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu Gyeongsangbuk-do, 41404, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun Jeollanam-do, , Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Chung-Ang University Hospital
Seoul , 06973, Korea, Republic of
Seoul National University Hospital
Seoul , 3080, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Lodz , 90-24, Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan , 60-69, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa , 02-03, Poland
Pan American Oncology Trials, LLC
San Juan , 902, Puerto Rico
RBIH "Ivanovo Regional Oncological Dispensary"
Ivanovo , 15304, Russian Federation
"VitaMed" LLC
Moscow , 12951, Russian Federation
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
Moscow , , Russian Federation
SBHI of Novosibirsk
Novosibirsk , , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
Pesochnyy , 19775, Russian Federation
Pavlov First Saint Petersburg State Medical University
Saint Petersburg , , Russian Federation
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara , 44301, Russian Federation
SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"
Volgograd , , Russian Federation
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl , 15005, Russian Federation
Hospital Clinic de Barcelona
Barcelona , 8036, Spain
Hospital de Basurto
Bilbao , , Spain
Hospital General Universitario de Elche
Elche , , Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario HM Madrid Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , , Spain
Hospital Regional Universitario de Malaga
Málaga , 29010, Spain
Complejo Hospitalario de Navarra
Pamplona , , Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia
Valence , , Spain
Initia Oncologia, SLP
Valencia , , Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Acibadem Adana Hospital
Adana , 1130, Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara , 6105, Turkey
Akdeniz University Medical Faculty
Antalya , 7058, Turkey
Inonu Uni. Med. Fac.
Malatya , 44280, Turkey
Velindre Cancer Centre
Cardiff , , United Kingdom
Sarah Cannon Research Institute UK
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

997

Study ID:

NCT03777657

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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